(38 days)
The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical chemistry analyzers for the quantitative determination of creatine kinase activity in human serum. Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.
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The provided text is a 510(k) premarket notification letter from the FDA regarding the Olympus Creatine Kinase Reagent. It confirms that the device is substantially equivalent to legally marketed predicate devices and can proceed to market. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about the studies mentioned in sections 2 through 9, as this information is not present in the provided document.
The document primarily focuses on:
- The FDA's determination of substantial equivalence for the Olympus Creatine Kinase Reagent.
- The regulatory classification (Class II).
- The intended use of the device (quantitative determination of creatine kinase activity in human serum for diagnosis and treatment of myocardial infarction and muscle disease).
- General regulatory requirements for marketing the device.
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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles a human figure with three wavy lines extending from the head, possibly representing hair or movement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN 2 0 2000
Olympus Diagnostics GMBH c/o Ms. Laura Storms-Tyler Olympus America Inc. Two Corporate Center Drive Melville, New York 11747
Re: K994189
Trade Name: Olympus Creatine Kinase Reagent Regulatory Class: II Product Code: CGS Dated: December 9, 1999 Received: December 13, 1999
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K994189 |
|---|---|
| Device Name: Olympus Creatine Kinase Reagent |
Indications for Use:
The Olympus Creatine Kinase reagent is intended for use in Olympus automated clinical chemistry analyzers for the quantitative determination of creatine kinase activity in human serum.
Measurements of creatine kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.
Lian Coggin
(Division Sign-Off) Division of Clinical Laboratory Laboratory Levices 510(k) Number ...
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.